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| Name | Class |
|---|---|
| MACROGEN | OTHER |
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Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of patients is rapidly becoming established as a useful source of information to aid clinical decision-making. This study is aimed to to compare concordance rate between tissue based cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by NGS technique).
This study is comprised of two cohorts as below:
Cohort A: inoperable, untreated, non-small cell lung cancer patients
Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents including immune checkpoint inhibitors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy |
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| Cohort B | Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MACROGEN Pan Cancer Panel (Tier 2) | Diagnostic Test | This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes. |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance rate | Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA | an average of one year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | To evaluate prognostic role of ctDNA concentration in NSCLC | an average of one year |
| Frequency of actionable genomic change | To determine the frequency of actionable oncogenic genes in NSCLC |
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Inclusion Criteria:
Provision of informed consent prior to any study specific procedures, sampling, and analyses
Pathologically confirmed non-small cell lung cancer
Male or female, aged at least 20 years
Matches one of two criteria :
Exclusion Criteria:
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Inoperable non-small cell lung cancer with two cohorts as below:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | 463-707 | South Korea |
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Cancer panel analysis will be done with patients tumro tissue and ctDNA
| an average of one year |
| Overall survival by treatment | To evaluate the survival of patients treated with genotype-directed therapy in daily practice | an average of one year |